Fresenius Kabi Oncology Limited — Gemcitabine Exporter Profile
Indian Pharmaceutical Exporter · #1 for Gemcitabine · $6.9M export value · DGFT Verified
Fresenius Kabi Oncology Limited is the #1 Indian exporter of Gemcitabine with $6.9M in export value and 339 verified shipments. Fresenius Kabi Oncology Limited holds a 14.8% market share in Gemcitabine exports across 20 countries. The company exports 16 pharmaceutical products worth $117.2M across 3 therapeutic categories.
Fresenius Kabi Oncology Limited — Gemcitabine Export Profile: Buyers & Destinations

Where Does Fresenius Kabi Oncology Limited Export Gemcitabine?
| Country | Value | Shipments | Share |
|---|---|---|---|
| THAILAND | $1.9M | 66 | 31.7% |
| GERMANY | $1.4M | 64 | 22.8% |
| PAKISTAN | $689.0K | 24 | 11.3% |
| MALAYSIA | $480.2K | 29 | 7.9% |
| VIETNAM | $286.1K | 14 | 4.7% |
| VIETNAM, DEMOCRATIC REP. OF | $184.8K | 10 | 3.0% |
| NEPAL | $166.3K | 17 | 2.7% |
| SOUTH AFRICA | $126.4K | 8 | 2.1% |
| MYANMAR | $114.5K | 13 | 1.9% |
| OMAN | $112.7K | 7 | 1.9% |
Fresenius Kabi Oncology Limited exports Gemcitabine to 24 countries. The largest destination is THAILAND accounting for 31.7% of Fresenius Kabi Oncology Limited's Gemcitabine shipments, followed by GERMANY (22.8%) and PAKISTAN (11.3%). These destinations reflect Fresenius Kabi Oncology Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Gemcitabine from Fresenius Kabi Oncology Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| FRESENIUS KABI DEUTSCHLAND GMBH | GERMANY | $1.4M | 64 |
| FRESENIUS KABI (THAILAND) LTD., | THAILAND | $590.3K | 21 |
| FRESENIUS KABI (THAILAND) LTD | THAILAND | $463.8K | 13 |
| FRESENIUS KABI MALAYSIA SDN BHD | MALAYSIA | $456.4K | 27 |
| FRESENIUS KABI THAILAND LIMITED | THAILAND | $334.6K | 12 |
| ATCO PHARMA INTERNATIONAL PVT LTD | PAKISTAN | $300.5K | 11 |
| FRESENIUS KABI THAILAND LTD | THAILAND | $295.8K | 9 |
| ATCO PHARMA INTERNATIONAL (PVT) LTD | PAKISTAN | $266.6K | 8 |
| BRANCH OF ZUELLIG PHARMA, VIETNAM L | VIETNAM, DEMOCRATIC REP. OF | $194.5K | 9 |
| FRESENIUS KABI(THAILAND)LTD | THAILAND | $125.3K | 6 |
Fresenius Kabi Oncology Limited supplies Gemcitabine to 69 buyers globally. The largest buyer is FRESENIUS KABI DEUTSCHLAND GMBH (GERMANY), followed by FRESENIUS KABI (THAILAND) LTD., (THAILAND) and FRESENIUS KABI (THAILAND) LTD (THAILAND). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Gemcitabine Export Value and How Much Does Fresenius Kabi Oncology Limited Contribute?
India exported $36.6M worth of Gemcitabine through 2,938 shipments from 248 suppliers to 125 countries, serving 676 buyers globally. Fresenius Kabi Oncology Limited contributes $6.9M to this total, accounting for 14.8% of India's Gemcitabine exports. Fresenius Kabi Oncology Limited ships Gemcitabine to 24 countries through 69 buyers.
What Is the Average Shipment Value for Fresenius Kabi Oncology Limited's Gemcitabine Exports?
Fresenius Kabi Oncology Limited's average Gemcitabine shipment value is $20.2K per consignment, based on 339 shipments totaling $6.9M. The largest destination is THAILAND (31.7% of Fresenius Kabi Oncology Limited's Gemcitabine exports).
How Does Fresenius Kabi Oncology Limited Compare to Other Indian Gemcitabine Exporters?
Fresenius Kabi Oncology Limited ranks #1 among 248 Indian Gemcitabine exporters with a 14.8% market share. The top 3 exporters are FRESENIUS KABI ONCOLOGY LIMITED ($6.9M), EUGIA PHARMA SPECIALITIES LIMITED ($5.9M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($5.8M). Fresenius Kabi Oncology Limited processed 339 shipments to 20 destination countries.
What Gemcitabine Formulations Does Fresenius Kabi Oncology Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| GEMCITABINE KABI INJ. 1000MG/26.3ML VIAL | $129.4K | 4 |
| Gemita (Gemcitabine) USP Inj. 1gm Vial B | $128.9K | 3 |
| GEMITA ( GEMCITABINE ) USP INJ. 1.4GM/VI | $114.4K | 3 |
| GEMITA (GEMCITABINE)INJ.1GM/VIAL B NO.87 | $100.0K | 2 |
| GEMITA ( GEMCITABINE ) USP INJ. 1GM/VIAL | $95.7K | 4 |
| GEMITA GEMCITABINE USP INJ. 1.4GM/VI | $91.1K | 2 |
| GEMITA ( GEMCITABINE ) INJ. 1GM/26.3ML V | $88.5K | 2 |
| GEMCITABINE KABI INJ. 1000MG/26.3ML VIAL(BATCH NO. 87250051AD, MFG. DT. 02/2025, EXP. DT. 01/2027) | $83.4K | 3 |
| GEMCITABINE INJ.2000MG/52.6ML VIAL B.NO. | $71.5K | 2 |
| GEMITA GEMCITABINE USP INJ. 1.4GM/VIAL | $70.4K | 2 |
Fresenius Kabi Oncology Limited exports 295 distinct Gemcitabine formulations including tablets, capsules, syrups, and combination drugs. The top formulation is GEMCITABINE KABI INJ. 1000MG/26.3ML VIAL with 4 shipments worth $129.4K.
Regulatory Requirements: Exporting Gemcitabine to Key Markets
What Fresenius Kabi Oncology Limited must comply with to export Gemcitabine to its top destination countries
Germany — BfArM/EMA
Approval Process
Marketing Authorisation via Decentralized or Mutual Recognition Procedure under EU Directive 2001/83/EC. CTD Module 1–5 dossier required.
Timeline: 12–18 months via Decentralized Procedure
GMP & Export Requirements
EU GMP (EudraLex Vol. 4); GMP certificate from EU competent authority; WHO Prequalification accepted as supporting evidence
Certificate of Pharmaceutical Product (CPP) from CDSCO; Written Confirmation for API export per EU requirements; EU FMD serialization mandatory
Note: Indian manufacturers must hold EU GMP certificate. EU Falsified Medicines Directive (FMD) serialization and tamper-evident packaging mandatory.
Regulatory information is provided for general reference based on publicly available guidelines. Requirements vary by formulation, dosage form, and therapeutic classification. Exporters should consult qualified regulatory affairs professionals for case-specific guidance.
How Does Fresenius Kabi Oncology Limited Compare to Nearest Gemcitabine Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | FRESENIUS KABI ONCOLOGY LIMITED ★ | $6.9M | 339 | 20 | $20.2K |
| 2 | EUGIA PHARMA SPECIALITIES LIMITED | $5.9M | 188 | 2 | $31.4K |
| 3 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $5.8M | 137 | 3 | $42.3K |
Fresenius Kabi Oncology Limited ranks #1 among 248 Indian Gemcitabine exporters. Average shipment value of $20.2K compared to the market average of $147.4K. The closest competitors by value are EUGIA PHARMA SPECIALITIES LIMITED and SUN PHARMACEUTICAL INDUSTRIES LIMITED.
Which Indian Ports Ship Gemcitabine Exports?
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 538 | 18.3% |
| SAHAR AIR CARGO ACC (INBOM4) | 393 | 13.4% |
| SAHAR AIR | 370 | 12.6% |
| DELHI AIR | 358 | 12.2% |
| Delhi Air | 131 | 4.5% |
| HYDERABAD ICD (INSNF6) | 88 | 3.0% |
| Bombay Air | 77 | 2.6% |
| NHAVA SHEVA SEA (INNSA1) | 66 | 2.2% |
What Other Oncology Products Does Fresenius Kabi Oncology Limited Export?
Fresenius Kabi Oncology Limited also exports these oncology products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Fresenius Kabi Oncology Limited's Gemcitabine Exports
The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like FKOL. The Israel-Iran conflict has led to disruptions in Red Sea shipping routes, causing maritime carriers to suspend bookings and reroute vessels around the Cape of Good Hope. These changes have resulted in increased freight charges and extended transit times, posing significant risks to time-sensitive pharmaceutical shipments. The Pharmaceutical Export Promotion Council of India (Pharmexcil) estimates potential losses ranging from ₹2,500 crore to ₹5,000 crore due to these disruptions. (fortuneindia.com)
Conversely, U.S.-China trade tensions have created openings for Indian pharmaceutical companies. The U.S. has imposed tariffs on Chinese goods, including pharmaceuticals, prompting American importers to seek alternative suppliers. This shift has benefited Indian exporters, as evidenced by the U.S. accounting for approximately 34.5% of India's pharma exports, valued at around $10.5 billion. (actizaindustry.com) However, the U.S. administration's fluctuating tariff policies, including threats of increased tariffs on pharmaceutical imports, necessitate vigilance and adaptability from exporters like FKOL. (lemonde.fr)
In the European Union, regulatory changes such as the Falsified Medicines Directive (FMD) impose stringent requirements on pharmaceutical imports. Compliance with these regulations demands significant investment in serialization and traceability systems. For FKOL, ensuring adherence to such standards is crucial to maintaining access to the lucrative EU market and upholding its reputation for quality and reliability.
Fresenius Kabi Oncology Limited — Regulatory Compliance & Quality Standards
The global pharmaceutical industry is witnessing heightened regulatory scrutiny, with agencies like the FDA and WHO emphasizing Good Manufacturing Practices (GMP) compliance. Indian exporters, including FKOL, must navigate this evolving landscape to sustain their market positions. Notably, the FDA has increased inspections of Indian manufacturing facilities, with over 200 inspections conducted in 2023 and plans to escalate this number in 2024. (fact.net.in)
FKOL's commitment to quality is evident in its state-of-the-art Research & Development center in Gurgaon, India. The facility focuses on developing next-generation cytotoxic and cytostatic therapies, ensuring that products meet the highest quality standards irrespective of the target market. (fresenius-kabi-oncology.com) This proactive approach to quality assurance positions FKOL favorably in a competitive and regulated global market.
About Fresenius Kabi Oncology Limited
Fresenius Kabi Oncology Limited exports 16 products worth $117.2M. Beyond Gemcitabine, top products include Carboplatin, Paclitaxel, Oxaliplatin, Irinotecan, Pemetrexed. View the complete Fresenius Kabi Oncology Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Gemcitabine — including regulatory updates, trade policy changes, and competitive landscape analysis — will be available in an upcoming update. This section will feature AI-researched insights from verified industry sources, government notifications, and market reports.
Official References & Regulatory Resources
- CDSCO India
- Pharmexcil
- IBEF — India Pharma Industry
- Ministry of Commerce — Pharma Exports
- India Trade Statistics (DGFT)
Verify manufacturer licensing and export certifications with the official agencies above.
Research Methodology & Data Transparency
Suresh Sormare
Verified AuthorPharmaceutical Export-Import Analyst & Trade Intelligence Expert
Suresh Sormare is a pharmaceutical export-import analyst with deep expertise in Indian Customs (DGFT) data, HS code classification, and global pharmaceutical supply chains. His analysis covers 10M+ shipment records across 150+ countries and is used by manufacturers, procurement agencies, and trade consultants worldwide. Suresh specializes in identifying verified suppliers and buyers from customs records, mapping bilateral pharmaceutical trade corridors, analyzing tariff structures and regulatory frameworks across 170+ destination markets, and benchmarking competitive positioning for finished pharmaceutical formulations. His methodology combines granular customs transaction data with regulatory intelligence from FDA, EMA, WHO, CDSCO, and 40+ national drug authorities to deliver actionable trade insights for the pharmaceutical formulations sector.
linkedin.com/in/sureshsormarePrimary Data Source
All trade data is sourced from Indian Customs (DGFT) official shipping bill records — the authoritative government database for India's pharmaceutical trade. Each verified record contains exporter name, consignee (buyer) name, detailed product description, quantity, declared FOB value (USD), port of loading, destination country, and shipment date.
Analysis Methodology
- 1.Product Matching: Gemcitabine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Fresenius Kabi Oncology Limited matched across shipments using name normalization, accounting for company name formatting variations.
- 3.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation. This removes the impact of unusually large one-off transactions that could distort company rankings.
- 4.Verified Records: This page is backed by 356 individual customs records matching Fresenius Kabi Oncology Limited exporting Gemcitabine, covering 295 formulations to 24 countries via 69 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 125+ countries, 676+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Gemcitabine Export Data from Fresenius Kabi Oncology Limited
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Fresenius Kabi Oncology Limited
Full Company Profile →
16 products · $117.2M total trade · 3 categories
Gemcitabine Stats
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Trade data sourced from Indian Customs (DGFT) export shipment records. Values represent FOB export value in USD. Market share calculated relative to total Indian pharmaceutical exports for Gemcitabine. For current shipment-level data, contact TransData Nexus.